Author: United States. Food and Drug Administration. Division of Microbiology
Publisher:
ISBN:
Category : Microbiology
Languages : en
Pages : 180
Book Description
Bacteriological Analytical Manual
Author: United States. Food and Drug Administration. Division of Microbiology
Publisher:
ISBN:
Category : Microbiology
Languages : en
Pages : 180
Book Description
Publisher:
ISBN:
Category : Microbiology
Languages : en
Pages : 180
Book Description
Food and Drug Administration, Laboratory Analysis of Product Samples Needs to be More Timely
Author: United States. General Accounting Office
Publisher:
ISBN:
Category : Laboratories
Languages : en
Pages : 72
Book Description
A primary responsibility of the Food and Drug Administration (FDA) is to protect the American consumer from adulterated or misbranded (violative) products. The role of FDA's field laboratories in accomplishing this mission is critical. They test numerous samples of products for possible violations. When violative products are identified, FDA takes regulatory actions, including seizures, to remove them from the market. Removing violative products from the market through seizure takes time. As the time frame for action increases, so does the amount of violative products reaching the consumer. This report discusses (1) the timeliness of field laboratories in processing product samples to determine if they are violative and (2) measures that can be implemented to bring about improvements.
Publisher:
ISBN:
Category : Laboratories
Languages : en
Pages : 72
Book Description
A primary responsibility of the Food and Drug Administration (FDA) is to protect the American consumer from adulterated or misbranded (violative) products. The role of FDA's field laboratories in accomplishing this mission is critical. They test numerous samples of products for possible violations. When violative products are identified, FDA takes regulatory actions, including seizures, to remove them from the market. Removing violative products from the market through seizure takes time. As the time frame for action increases, so does the amount of violative products reaching the consumer. This report discusses (1) the timeliness of field laboratories in processing product samples to determine if they are violative and (2) measures that can be implemented to bring about improvements.
U.S. Food and Drug Administration Laboratory, Irvine, California, Proposed
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 270
Book Description
Publisher:
ISBN:
Category :
Languages : en
Pages : 270
Book Description
Microbiology Laboratory Guidebook
Author: United States. Food Safety and Inspection Service. Microbiology Division
Publisher:
ISBN:
Category : Agricultural microbiology
Languages : en
Pages : 556
Book Description
Publisher:
ISBN:
Category : Agricultural microbiology
Languages : en
Pages : 556
Book Description
FDA Bioequivalence Standards
Author: Lawrence X. Yu
Publisher: Springer
ISBN: 1493912526
Category : Medical
Languages : en
Pages : 472
Book Description
This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.
Publisher: Springer
ISBN: 1493912526
Category : Medical
Languages : en
Pages : 472
Book Description
This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.
Food and Drug Administration Procedures for the Selection of Laboratory Sites
Author: United States. Congress. House. Government Operations
Publisher:
ISBN:
Category :
Languages : en
Pages : 86
Book Description
Publisher:
ISBN:
Category :
Languages : en
Pages : 86
Book Description
Food and Drug Administration Procedures for the Selection of Laboratory Sites
Author: United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee
Publisher:
ISBN:
Category : Chemical laboratories
Languages : en
Pages : 88
Book Description
Considers FDA procedure for selecting sites for laboratory facilities. Focuses on the location of Laboratory No. 2 in Beltsville, Md.
Publisher:
ISBN:
Category : Chemical laboratories
Languages : en
Pages : 88
Book Description
Considers FDA procedure for selecting sites for laboratory facilities. Focuses on the location of Laboratory No. 2 in Beltsville, Md.
Food and Drug Administration
Author: United States. General Accounting Office
Publisher:
ISBN:
Category : Laboratories
Languages : en
Pages : 68
Book Description
Publisher:
ISBN:
Category : Laboratories
Languages : en
Pages : 68
Book Description
National Shellfish Sanitation Program
Author: DIANE Publishing Company
Publisher: DIANE Publishing
ISBN: 0788124234
Category : Shellfish fisheries
Languages : en
Pages : 152
Book Description
Contents: general administrative procedures (state laws and regulations, general administrative procedures to be used by States); laboratory procedures (bacteriological, toxicological, chemical and physical, and quality assurance procedures); growing area survey and classification; controlled relaying; patrol of shellfish harvesting areas; control of harvesting (licensing and permitting harvesters, penalties and sanctions); and aquaculture. Appendices: suggested contingency plan for control of marine biotoxins; and much more. Extensive bibliography.
Publisher: DIANE Publishing
ISBN: 0788124234
Category : Shellfish fisheries
Languages : en
Pages : 152
Book Description
Contents: general administrative procedures (state laws and regulations, general administrative procedures to be used by States); laboratory procedures (bacteriological, toxicological, chemical and physical, and quality assurance procedures); growing area survey and classification; controlled relaying; patrol of shellfish harvesting areas; control of harvesting (licensing and permitting harvesters, penalties and sanctions); and aquaculture. Appendices: suggested contingency plan for control of marine biotoxins; and much more. Extensive bibliography.
Construction of Regional Office and Laboratory, Site Specific, Jamaica Site, Queen County
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 532
Book Description
Publisher:
ISBN:
Category :
Languages : en
Pages : 532
Book Description